Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000611820
Ethics application status
Not yet submitted
Date submitted
6/06/2012
Date registered
7/06/2012
Date last updated
7/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a computer-based patient education programme in physiotherapy rehabilitation for shoulder injuries.
Scientific title
The effect of a computer-based patient education programme on rehabilitation adherence and shoulder function when used as an adjunct to physiotherapy in patients with shoulder injuries.
Secondary ID [1] 280613 0
Pilot study registration ID: ACTRN12609000813280
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adherence to physiotherapy rehabilitation using computer-based patient education (CBPE). 286625 0
Soft tissue injuries of the shoulder 286647 0
Condition category
Condition code
Physical Medicine / Rehabilitation 286903 286903 0 0
Physiotherapy
Musculoskeletal 286935 286935 0 0
Other muscular and skeletal disorders
Injuries and Accidents 286946 286946 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The computer-based patient education (CBPE) programme is interactive and tailored to gender and broadly to age. It consists of shoulder anatomy, shoulder exercises, adherence enhancing strategies, advice on functional activities and quizzes. Participants will be directed by the researcher to the relevant content for their disorder. The programme will be available to the participants for 8 weeks, during which time they can access it at any time. They will record their exercise adherence in a self-report diary. Participants in the intervention group will make action and coping plans with the researcher at the beginning of the study. Over the 8 weeks study period all participants will continue receiving standard physiotherapy treatment.
Intervention code [1] 285010 0
Rehabilitation
Intervention code [2] 285037 0
Behaviour
Comparator / control treatment
General information about shoulder structure and function, shoulder injuries and the costs they incur. This information will be available on a DVD that participants in the control group will be issued with at baseline and which they will be able to access in their own time over the 8 weeks study period. All participants will receive standard physiotherapy treatment over this time.
Control group
Active

Outcomes
Primary outcome [1] 287262 0
Functional outcomes of the shoulder. This variable will be assessed using the Disabilities of Arm, Shoulder and Hand questionnaire (DASH) and the P4 pain scale (Spadoni, Stratford, Solomon, & Wishart, 2004).
Timepoint [1] 287262 0
Baseline and at 8 weeks (time 2)
Primary outcome [2] 287282 0
Adherence to home-based physiotherapy rehabilitation
Timepoint [2] 287282 0
Daily self-report for 8 weeks of the home-based programme
Secondary outcome [1] 297778 0
Self-efficacy with the physiotherapy programme will be measured by action self-efficacy, maintenance self-efficacy and recovery self-efficacy self report questionnaires. These validated questionnaires have been adapted from the Health Action Process Approach (HAPA) model (Scholz, U., Sniehotta, F., & Schwarzer, R. (2005).
Timepoint [1] 297778 0
Action, maintenance and recovery self-efficacy will be measured at baseline and time 2 (8 weeks later).
Secondary outcome [2] 297779 0
Behavioural intentions will measured by a self-report questionnaire about the participants intentions to follow the physiotherapy. These validated questionnaires have been adapted from the Health Action Process Approach (HAPA) model (Scholz, U., Sniehotta, F., & Schwarzer, R., 2005).
Timepoint [2] 297779 0
Baseline
Secondary outcome [3] 297780 0
Knowledge. This will be measured by 10 multiple choice questions relating to shoulder structure and function, and behavioural strategies. Face and content validity were checked by a panel of experts that included patients, physiotherapists and educators
Timepoint [3] 297780 0
Measured at baseline and at 8 weeks (time 2)
Secondary outcome [4] 297781 0
Patient satisfaction with CBPE programme. It will be assessed by seven items adapted from the original 13 item Physiotherapy Patient Satisfaction Scale questionnaire (Bassett, S., Clark, C. H., McNair, P., & Harman, B., 2010). Participants will score each item using a 7 point Likert scale.
Timepoint [4] 297781 0
Measured at baseline and at 8 weeks (time 2)

Eligibility
Key inclusion criteria
Soft tissue injury of the shoulder
At least 16 years of age
Understand written and spoken English
Have no cognitive disorders that could impede learning.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any health conditions that may adversely effect the participants ability to undertake shoulder exercises.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prospective participants are referred from the treating physiotherapist who determines if the participants are eligible for inclusion in the trial. The researcher fully informs prospective participants about the study and their role in it. Those who wish to participate sign a consent form. They are then randomly allocated to either the CBPE or information DVD group. The method of randomisation is concealed from the treating physiotherapist who is unaware of the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated list of random allocation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment outside Australia
Country [1] 4345 0
New Zealand
State/province [1] 4345 0

Funding & Sponsors
Funding source category [1] 285372 0
Charities/Societies/Foundations
Name [1] 285372 0
Physiotherapy New Zealand Scholarship Award Trust Fund - to be submitted
Country [1] 285372 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Private Bag 9266
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 284231 0
None
Name [1] 284231 0
Address [1] 284231 0
Country [1] 284231 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287388 0
Northern Y - New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 287388 0
C/o Ministry of Health
PO Box 1031
Hamilton 3240
Ethics committee country [1] 287388 0
New Zealand
Date submitted for ethics approval [1] 287388 0
12/07/2012
Approval date [1] 287388 0
Ethics approval number [1] 287388 0
Ethics committee name [2] 287411 0
Auckland University of Technology Ethics Committee
Ethics committee address [2] 287411 0
Private Bag 92006
Auckland 1142
Ethics committee country [2] 287411 0
New Zealand
Date submitted for ethics approval [2] 287411 0
12/08/2012
Approval date [2] 287411 0
Ethics approval number [2] 287411 0

Summary
Brief summary
CBPE will improve rehabilitation outcomes, adherence, self-efficacy and knowledge for participants. CBPE can be developed using sound educational principles to foster patient understanding (see Mayer, 2001) and can incorporate behaviour changing strategies to enhance adherence (see Conner & Norman, 2005). Moreover, the facility for interactivity using computer programmes can increase patient involvement and allow programmes to be tailored to individual patients. Inherent to CBPE programmes, information is consistent and repeatable with access being limited only by computer availability. Patients can also offer multiple pathways to progress through programmes thereby accommodating individual learning styles. Although CBPE has been successfully developed in other sectors of healthcare (Keulers, Welters, Spauwen, & Houpt, 2007; Stinson et al., 2008; Stromberg, Ahlen, Fridlund, & Dahlstrom, 2002; Wetstone, Sheehan, Votow, Peterson, & Rothfield, 1985), there are no known programmes of this type for physiotherapy rehabilitation. Given the extent to which patient education is used in physiotherapy, the poor adherence to it and recent advances in technology, investigation into the effectiveness of CBPE is warranted.
Trial website
None at present
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34262 0
Address 34262 0
Country 34262 0
Phone 34262 0
Fax 34262 0
Email 34262 0
Contact person for public queries
Name 17509 0
Heather Clark
Address 17509 0
Department of Physiotherapy
North Shore Campus
Auckland University of Technology
Private Bag 92006
Auckland, 1142
Country 17509 0
New Zealand
Phone 17509 0
+64 9 921 9999 ext 7066
Fax 17509 0
+64 9 921 9620
Email 17509 0
[email protected]
Contact person for scientific queries
Name 8437 0
Heather Clark
Address 8437 0
Department of Physiotherapy
North Shore Campus
Auckland University of Technology
Private Bag 92006
Auckland, 1142
Country 8437 0
New Zealand
Phone 8437 0
+64 9 921 9999 ext 7066
Fax 8437 0
+64 9 921 9620
Email 8437 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseValidation of a comprehensive measure of clinic-based adherence for physiotherapy patients.2018https://dx.doi.org/10.1016/j.physio.2017.07.003
N.B. These documents automatically identified may not have been verified by the study sponsor.